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Be the first with the news that moves the market- Microbix Biosystems (TSX:MBX) has been granted European Union CE mark registration for its COVID-19 quality assessment products (QAPs)
- CE marking certifies conformity with the health, safety and environmental protection standards for products sold within the European Economic Area
- European distributors of the company’s products will now be able to sell the QAPs to clinical laboratories across 17 countries within the EU
- Microbix has also secured National Registration with the Italian Ministry of Health
- Microbix Biosystems (MBX) is currently up 3.13 per cent and is trading at C$0.33 per share at 12:25pm EDT
Microbix Biosystems (TSX:MBX) has been granted European Union CE mark registration for its COVID-19 quality assessment products (QAPs).
A CE marking certifies that a particular product meets the necessary standards regarding health, safety and environmental protection that are required within the European Economic Area (EEA). As such, it declares that the product may be sold freely within the EEA, regardless of its country of origin.
With the registration now secured, distributors of Microbix’s QAPs will be able to provide the products to their respective networks of clinical laboratories. This includes a total of 17 countries across the European Union and Nordic region.
In addition, the company has received National Registration with the Italian Ministry of Health.
There are currently four-dozen QAPs across Microbix’s PROCEEDx and REDx Controls tradenames, which aim to increase the accuracy of bacterial and viral diseases tests.
The QAPs span sexually-transmitted, gastrointestinal and respiratory infections. However, the CE marking only applies to the company’s positive and negative controls that relate to SARS-CoV-2, which causes COVID-19.
Cameron Groome, President and CEO of Microbix Biosystems, said the achievement of CE mark registration is a significant step.
“We’re pleased to have completed the process of registering our SARS-CoV-2 Controls to permit their sale as controls to clinical labs across the EU.
“Microbix’s distributors will now engage with European governments, health authorities, hospitals and laboratory chains, to make certain that EU healthcare systems can benefit from these Microbix products,” he said.
So far this year, Microbix has signed a host of new distribution agreements, including an arrangement with Alpha-Tec Systems to distribute its QAPs throughout the United States.
Microbix Biosystems (MBX) is up 3.13 per cent and is trading at C$0.33 per share at 12:25pm EDT.
